Implantable infusion pumping catheter

ABSTRACT

In some examples, an implantable infusion device using a piezoelectric and/or electrostrictive mechanical pumping catheter includes a reservoir configured to retain for a fluid to be dispensed within a patient, at least one piezoelectric and/or electrostrictive mechanical pumping catheter for dispensing the fluid contained within the reservoir, a transceiver, and a processor to regulate control the operation of the piezoelectric and/or electrostrictive mechanical pumping catheter.

PRIORITY APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.15/569,853, filed Oct. 27, 2017, which application is a U.S. NationalStage Filing under 35 U.S.C. 371 from International Application No.PCT/US2016/029331, filed on Apr. 26, 2016, and published asWO20161176192 on Nov. 3, 2016, which claims the benefit of priority toU.S. Provisional Patent Application No. 62/153,062, titled“PIEZOELECTRIC AND/OR ELECTROSTRICTIVE MECHANICAL IMPLANTABLE INFUSIONPUMPING CATHETER,” by Shane Maguire, and filed on Apr. 27, 2015, all ofwhich are incorporated herein by reference in their entirety.

This application claims the benefit of U.S. Provisional PatentApplication No. 62/153,062, titled “PIEZOELECTRIC AND/ORELECTROSTRICTIVE MECHANICAL IMPLANTABLE INFUSION PUMPING CATHETER,” byShane Maguire, and filed on Apr. 27, 2015, the entire content of whichbeing incorporated herein by reference.

TECHNICAL FIELD

This disclosure pertains generally, but not by way of limitation, tomedication delivery devices and more specifically to implantableinfusion devices.

BACKGROUND

It can be important to provide a localized implantable delivery systemin order to accurately present a medication, drug, or other fluid to aspecific region, or target site, of a patient. By delivering the drug orother fluid to the target site, a much lower dose can be given to thepatient, which can potentially avoid adverse side effects that can becaused by oral or injected administration of a medication or otherfluid.

Localized and controlled infusion of drugs or other fluids at theirdesired site of action can be preferable over other delivery approachesbecause it can reduce toxicity and increase treatment efficiency.Localized infusion has increasingly become important for a multitude ofmedical applications including, but not limited to: 1) cancer andneurodegenerative disorder treatment 2) pain management, 3) tissueengineering, 4) localized vascular and nervous system therapy.

Implantable infusion devices e.g., drug infusion pumps, were created tominimize the negative aspects such as infection and needle migration oftherapies that require external pump and catheter systems. Implantableinfusion devices developed to date typically include 1) a drug reservoirto contain the drug, 2) a control/circuit board, 3) wirelesscommunication/telemetry circuitry, 4) an injection port to inject druginto the reservoir, 5) an additional troubleshooting port for access tothe catheter, and 6) the ability to connect and/or use a catheter todeliver the drug to the intended site. Additionally, internal pumps canprovide the ability to bypass the blood brain barrier and thus can allowfor a hundredth, a thousandth, or even less, of the normal oral dose.

Localized delivery of the drug to a target site can be achieved bymanual delivery, but this can include repeated injections at the targetsite or delivery of the drug via a time released drug formulation. Thenegative aspects of a time released drug can include drug stabilityissues depending upon the duration of time over which the drug must bedelivered and the ability to have an accurately controlled delivery ofthe desired volume. Additionally, the volume of drug used forintravascular delivery can often require an order of magnitude or moreof the drug to be infused into the patient than that required forintrathecal delivery. This can avoid many of the drug side effects thatare normally generated by the larger doses of oral or even intravenouslydelivered drugs.

Existing external infusion systems include those mounted on an externalsupport or worn by the patient, using a drug pump and cathetercombination. Potential issues with patient use and adoption with thesesystems can include the following: 1) potential infection at the site ofentry into the patient's body, 2) recurrent battery replacement ortethered power supply, and 3) aesthetic and acceptance concerns by thepatients regarding appearance. Additionally, with these systems, thepatient may live a restricted lifestyle because of being tethered to anexternal device.

Recent approaches can infuse medicine to the target site via animplanted drug infusion pump and attached catheter system that allowsthe drug to be delivered directly to the desired site. Typically, theseapproaches use pneumatic, mechanical, electromagnetic, piston driven,and watch motor style pumps (gear driven) for delivering the selecteddrug to the site of interest. Implantable piston or gear driven basedpumps can be bulky and prone to mechanical wear and corrosion which maylead to premature failure and the need to surgically remove/replace thedrug delivery device.

Drug delivery devices can be programmed to infuse a variety of dosagesthat can be delivered at a rate from constant to widely variable overtime. The rate (dosage over time) can be programmed using electronics(processor, memory, etc.) contained within the electronic section of thepump. Typically, programming is performed via an external programmingdevice. The speed/rate of delivery is controlled by the rate thepiezo/electrostrictive elements are commanded to open/close as well bythe dimensions and flexation capabilities of the piezo/electrostrictivematerial in the pumping catheter segments.

Overview

In an example, this disclosure relates to an implantable infusion deviceusing a piezoelectric and/or electrostrictive mechanical pumpingcatheter. The implantable piezoelectric and/or electrostrictive infusioncatheter is comprised primarily of from two to any number ofpiezoelectric and/or electrostrictive pumping segments runningindependently, controllable in any order/sequence, and a reservoir fromwhich a fluid, gas, etc. is to be dispensed. The piezoelectric and/orelectrostrictive mechanical catheter for dispensing the fluid/gascontained within the reservoir acts as a fluid/gas transfer conduitworking together with a transceiver, an optional energy harvestingcircuitry, a wireless communication (telemetry) receive/send circuit,and an integrated circuit to regulate the operation of the piezoelectricand/or electrostrictive mechanical pumping catheter.

This overview is intended to provide a summary of the subject matter ofthe present patent application. It is not intended to provide anexclusive or exhaustive explanation of the invention. The detaileddescription is included to provide further information about the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various embodiments discussed in the presentdocument.

FIG. 1A is a conceptual view of an example of a portion of apiezoelectric and/or electrostrictive mechanical pumping catheter forcontrolling fluid flow, in accordance with this disclosure.

FIGS. 1B and 1C depict cross-sectional end views illustrating examplesof piezoelectric and/or electrostrictive pumping segments deforming aninterior of the catheter to pump a fluid, e.g., a therapeutic drug,through the lumen of the catheter.

FIG. 2 is a block diagram depicting an example implantable infusiondevice using a piezoelectric and/or electrostrictive mechanical pumpingcatheter, e.g., the piezoelectric and/or electrostrictive mechanicalpumping catheter of FIG. 1A.

FIGS. 3A-3B are conceptual diagrams illustrating an example of apiezoelectric and/or electrostrictive pump that can be used to implementvarious techniques of this disclosure.

FIG. 4 is a schematic diagram illustrating an example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.

FIG. 5 is a schematic diagram illustrating another example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.

FIG. 6 is a schematic diagram illustrating another example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.

FIG. 7 illustrates a block diagram of another example of an implantableinfusion device.

FIGS. 8A-8E depict conceptual diagrams illustrating a pumping sequenceof an example piezoelectric and/or electrostrictive pumping catheter, inaccordance with this disclosure.

DETAILED DESCRIPTION

As noted above, existing implantable infusion devices can suffer adrawback in their large and rigid design confining them to only beimplanted in specific locations. Also, pneumatic, gear driven, orelectromagnetic motorized piston driven pumps can consume large amountsof power, leading to a continual need to recharge if the pump is poweredby a rechargeable source (i.e., Li-Ion battery) or replace the devicewhen power is diminished to a level requiring replacement sooner thandesired if the pump is powered by a primary source (i.e., Lithiumbattery). The frequency of recharge or replacement can be dependent uponthe use of the implantable infusion device. Recharge may, for example,occur every eight to twenty-four hours and replacement (e.g., surgery toremove and implant another infusion pump) may occur every two to threeyears. Incorporation of a piezoelectric and/or electrostrictivemechanical pump may increase, e.g., double, or potentially triple, theoperational time of the implantable infusion device before a recharge orreplacement is required.

This disclosure describes implantable infusion devices that can utilizevarious piezoelectric and/or electrostrictive pumping techniques.Piezoelectric (also referred to as “piezo” in this disclosure) and/orelectrostrictive infusion devices as described in this disclosure canprovide several advantages over existing pumps including those usingrotational motor driven pumping, mechanisms, including, but not limitedto: 1) reduction in size, 2) enablement of a flexible design, 3)implantable in a multitude of locations within different sized patientsincluding infants and small children, 4) low energy consumption(requiring less time to power and recharge and/or less frequentreplacement), 5) low maintenance, 6) the introduction of energyharvesting enhancements and operation, and 7) the combination ofpiezo-electrical and/or electrostrictive pumping material into thedesign of a “catheter” based delivery system that incorporates the usageof single to multiple piezo and/or electrostrictive components thatfunction in a singular or plurality acting in parallel, series, orvarious specific orders of compression and release to pump fluid from areservoir to a target area.

Minimizing the size of the system, and avoiding the bulk of existingsystems, can allow the devices described in this disclosure to supportnew implant locations previously not feasible with existing infusionsystem. Examples of new implant locations, in addition to the typicallocations of the chest and buttock can include, but are not limited to,appendages (e.g., legs and arms), shoulders, back, and the head.Additionally, the system described in this disclosure can open animportant, new arena of implantable device usage, thereby allowingimplantation in infant and smaller patients due to the small sizeenabled by this design. Note: Processors 102 and 103 can be combinedinto a single processor, whereby references to 103 can be considered thesame as 102, Additionally, processors 202 and 203 can be combined into asingle processor, whereby references to 203 can be considered the sameas 202.

FIG. 1A is a conceptual view of an example of a portion of apiezoelectric and/or electrostrictive mechanical pumping catheter 10 forcontrolling fluid flow, in accordance with this disclosure. As describedin detail in this disclosure, the pumping catheter 10 can include atubular member 12 defining a lumen 14 with proximal and distal ends anddisposed about a plurality of deformable segments 16A-16F (referred tocollectively as segments 16), where each segment 16 can include apiezoelectric and/or electrostrictive pump, and a sheath 18, e.g., abiocompatible sheath, disposed about at least the plurality of segments.In addition, the pumping catheter 10 can include a single check valve,or plurality of check valves (not depicted), housed in the proximal anddistal ends, and in some configurations, distributed along the length ofthe pumping catheter between each of the pumping segments, to controlfluid flow. Although six segments 16 are depicted in FIG. 1A, thecatheter 10 can include more than six segments 16, or fewer than sixsegments 16.

The piezoelectric and/or electrostrictive pumping catheter 10 caninclude one or more piezoelectric and/or electrostrictive pumpingsegments 16. In example configurations that include a plurality ofpiezoelectric and/or electrostrictive segments 16, such as shown inFIGS. 1A-1C, the segments 16 can be arranged in series along the lengthof the catheter 10 and can be controlled independently.

In some example configurations, the segments 16 can be configured tooperate independently of each other, thereby forcing the fluid throughthe catheter, In some examples, the segments 16 can be substantiallyadjacent, e.g., one micron or less, to one another in the series. Inother examples, the segments 16 can be spaced apart from one another inthe series. In some example configurations, a check valve can be placedbetween each of the pumping segments to further control any backflowbetween these segments.

Each piezo segment 16 can include, for example, a piezoelectric materialengaged to at least two electrical contacts. Non-limiting examples ofpiezoelectric materials include quartz (Si0₂), as well as lithiumtantalite, polyvinylidene fluoride, and potassium sodium tartrate.Lead-free piezoelectric materials that can be used in various exampleimplementations include ceramics with a perovskite structure as ceramicswith a tungsten bronze structure. Other example piezoelectric materialscan include: BaTiO3, KNbO3, Ba2NaNb5O5, LiNbO3, Pb(ZrTi)O3, Ph2KNb5O15,BiFeO3, and NaxWO3. When control electronics 20 applies a voltagebetween at least, two electrodes/contacts 22A, 22B using wires 24A, 24B(collectively referred to as wires 24) in communication with the controlcircuitry 20, the piezoelectric material of the deformable segment canflex, e.g., inwardly or outwardly, to close or open the segment 16,respectively. In this manner, the piezoelectric materials are configuredto receive control signals and, in response, controllably deform theirrespective segments to control a rate of fluid flow through the catheterlumen and/or a volume of fluid through the lumen.

Instead of or in addition to piezoelectric materials, electrostrictivematerials can be used to implement various techniques of thisdisclosure. Electrostrictive materials have properties that are similarto piezoelectric materials and can produce a mechanical change, e.g.,deformation, in response to the application of an electric field.

Instead of or in addition to piezoelectric and electrostrictivematerials, electroactive polymers (“EAP”) can be used to implementvarious techniques of this disclosure. Electroactive polymers can bedeformed when an electric field is applied.

In some examples, the segments 16 can have a “normal” (or natural) statesuch as a normally open state or normally closed state. A normally openstate is one in which, absent the application of a voltage to the piezomaterial and/or electrostrictive on the segment, the segment is open andallows fluid to flow through it. A normally closed state is one inwhich, absent the application of a voltage to the piezo and/orelectrostrictive material on the segment, the segment is closed andprevents fluid from flowing through the segment.

Using the techniques of this disclosure, one or more of the piezo and/orelectrostrictive segments 16 can be used to create a piezoelectricand/or electrostrictive pumping catheter 10. In the example shown inFIG. 1A, for example, a plurality of segments 16 can be longitudinallypositioned along the length of the catheter 10 and controlled by thecontrol electronics 20 to create a pumping action that can pump fluidfrom a proximal reservoir (not depicted in FIG. 1A) to a distalconnection point or catheter delivery point. As a voltage signal (orcontrol signal) is applied across the contacts 22A, 22B engaged to thepiezo and/or electrostrictive material of a normally closed (“NC”)segment, the segment 16 can open and as a voltage signal is appliedacross the contacts engaged to the piezo and/or electrostrictivematerial of a normally open (“NO”) segment, the segment 16 can close. Acontrol signal may be application of a voltage, current, magnetic field,electric field, or any combination thereof. The control electronics 20can control the timing and coordination of the voltage signals appliedto the piezo and/or electrostrictive segments to create a pumpingaction.

For example, in the non-limiting example configuration shown in FIG. 1A,the direction of the fluid flow is from the top of the figure (from afluid reservoir) through six piezo and/or electrostrictive segments(segments 16A-16F). Some example configurations can include more or lessthan six piezo and/or electrostrictive segments.

The control electronics 20 can apply a first voltage signal to NCsegment 16A, which can cause segment 16A to open and draw in fluid. Thecontrol electronics 20 can remove the voltage signal to NC segment 16A,which can cause segment 16A to return to its normally closed state andpush the portion of the fluid into NO segment 16B. The controlelectronics 20 can apply a second voltage signal to NO segment 16B,which can cause segment 16B to close and push the portion of the fluidinto NO segment 16C. The control electronics 20 can apply a thirdvoltage signal to NO segment 16C, which can cause segment 16C to closeand push the portion of the fluid into NO segment 16D. The controlelectronics 20 can apply a fourth voltage signal to NO segment 16D,which can cause segment 16D to close and push the portion of the fluidinto NO segment 16E. The control electronics 20 can apply a fifthvoltage signal to NO segment 16E, which can cause segment 16E to close,and the control electronics 20 can apply a sixth voltage signal to NCsegment 16F, which can cause segment 16F to open, which will push theportion of the fluid into NC segment 16F. The control electronics 20 canremove the voltage signal to NC segment 16F, which can cause segment 16Fto return to its normally closed state and push the portion of the fluidout of the distal tip of the catheter, for example.

FIGS. 1B and 1C depict cross-sectional end views illustrating examplesof the piezoelectric and/or electrostrictive pumping segments 16deforming an interior of the catheter 10 to pump a fluid, e.g., atherapeutic drug, through the lumen of the catheter 10. In the exampleshown in FIG. 1B, the catheter 10 can include an outer tube 28, e.g., atube made of Kevlar® (manufactured by DuPont) or similar high tensilestrength, but fully flexible, material, and an inner seal tube (layer)30. In some example configurations, the bottom 32 of the inner seal tube30 flexes minimally or not at all. The catheter 10 can include flexpoints 34 on one or both sides of the outer tube 28 and the inner tube30. A fluid 36, e.g., a therapeutic drug, is depicted in the lumen ofthe catheter 10. At the top of the catheter 10 and disposed between theouter tube 28 and the inner tube 30 is piezoelectric and/orelectrostrictive material 26 forming, for example, a plurality ofpiezoelectric and/or electrostrictive pumps or pumping segments 16 ofthe pumping catheter 10.

In the example shown in FIG. 1C, a first piezoelectric and/orelectrostrictive material 26A is shown compressing the inner seal tube30 in a first segment, e.g., in a first segment 16F, into a closedposition during pumping action to prevent backflow. A secondpiezoelectric and/or electrostrictive material 26B of an adjacent secondsegment is also depicted, e.g., a second segment 16E. The catheter 10can further include a membrane wall 38 positioned between adjacentsegment 16. As seen in FIG. 1C, the membrane wall 38 can stretch to sealthe catheter 10 at a segment 16 to prevent backflow.

As an alternative to piezoelectric materials, electrostrictivematerials, and electroactive polymers (“EAP”), shape-memory alloys (alsoreferred to as memory metal or memory alloy) can be used in the pumpingcatheter of FIGS. 1A-1C (and in the system of FIG. 4 below).Shape-memory alloys, e.g., nickel-titanium, exhibit “shape memory” suchthat the alloy can return to an original shape after deformation, e.g.,when the alloy is heated.

Referring to FIGS. 1A-1C, instead of using piezoelectric and/orelectrostrictive material 26 in segments 16, each segment 16 can includea shape-memory alloy (SMA) 26. In each segment 16, the SMA 26 can beaffixed to a portion of the inner seal tube 30. In an exampleconfiguration, the SMA 26 of each segment 16 can have an original statelike material 26A in FIG. 1C, where the material 26A compresses theinner seal tube 30 into a closed position. As a tubular structure, theresilient inner seal tube 30 can naturally bias the SMA 26 of eachsegment outwardly, however, to deform the SMA 26 into a second, openposition, like the material 26B in FIG. 1C. To reset the SMA 26 suchthat it returns to its original, closed state, control electronics 20can apply a voltage to the SMA 26 via the wires 24, which can heat theSMA 26 sufficiently for it to recover its shape and close the segment.

FIG. 2 is a block diagram depicting an example implantable infusiondevice 100 using a piezoelectric and/or electrostrictive mechanicalpumping catheter, e.g., the piezoelectric and/or electrostrictivemechanical pumping catheter of FIG. 1A. The control electronics 20depicting in various figures of this disclosure can include one or morecomponents depicted in FIG. 2 (or FIG. 7 below). The implantableinfusion device or system 100 can include a first processor 103, e.g.,an embedded controller/processor, to control power and communicationfunctionality associated with a power source 104, e.g., battery, arecharge circuit 113 for recharging the power source 104, an energyharvesting circuit 106, and a communication interface 108. In someexamples, the power source 104 can be a low voltage battery, e.g., about3 volts.

The device 100 can further include a second processor 202, orincorporate this functionality into processor 103 to control, or be incommunication with, a piezoelectric and/or electrostrictive mechanicalpumping catheter, such as pumping catheter 10 shown in FIGS. 1A-1C, thatcan include N number of segments 110-1 through 110-N, a drug reservoir109, an alarm 107, and a sensing interface 111, configured to receiveinformation from one or more sensors, including biological sensors suchas, but not limited to, heart rate, blood pressure, blood oxygenation,motion (roll, pitch, yaw, x, y, x, speed, etc.) sensors including butnot limited to GPS, gyro, rate, rotational, and body temperature.

The implantable infusion device 100 can include one or more of thestorage devices, communication and alarm/sensing interfaces, powersources, piezoelectric and/or electrostrictive mechanical pumps,reservoirs, and recharge and energy harvesting circuits.

The reservoir 109 can be constructed of one or more materials, includingbut not limited to silicon, titanium, synthetic fibers such as Kevlar®,and various braided sheathing constructions. The reservoir can be ahard, rigid, or flexible container in various example configurations.

Catheter segments 110-1 through 110-1 may be made from a biocompatiblematerial or uniformly coated with a biocompatible material to attain aspecified biocompatibility. In some examples, the biocompatiblematerial(s) can include natural or synthetic compounds or elementsincluding, but not limited to: metals, for example titanium or titaniumalloy, or plastics such as medical grade polyvinyl chloride (PVC),polyethylene (PE), polycarbonate, or polyether ether ketone (PEEK).

Because the implantable infusion device 100 can be implanted in apatient's body, it can be desirable to reduce the overall size ordimensions of the device to minimize trauma, reduce the capability tofeel the device external to the patient, and allow for the device to beimplanted into smaller patients, including infants. In some instances,the implantable infusion device implantation can be limited to specificregions of the body, e.g., such as the abdomen, buttock, shoulder,skull, etc., which can further constrain the size.

In some example configurations, the reservoir 109 can also include anoutlet port (or catheter port) to connect to the pumping catheter fordelivery of medication to a target site (not shown). In another example,the catheter-based pumping system, e.g., as shown in FIG. 1A, cancontain a refill port 116 attached to the reservoir 109 to refill themedicine or drug when it is depleted.

In the example shown in FIG. 2, implantable infusion device 100 caninclude a processor 103 and memory 115. The processor 103 may include,for example, one or more general-purpose microprocessors, speciallydesigned processors, application specific integrated circuits (ASIC),field programmable gate arrays (FPGA), a collection of discrete logic,and/or any type of processing device capable of executing the techniquesdescribed in this disclosure. In some examples, the processor 103 (orany other processors described in this disclosure) can be described as acomputing device. In some examples, the memory 115 can be configured tostore program instructions (e.g., software instructions) that areexecuted by the processor 103 to carry out the processes or methods ofoperating and programming the implantable infusion device described inthis disclosure. In other examples, the processes or methods describedin this disclosure may be executed by specifically programmed circuitryof the processor 103. In some examples, the processor 103 can beconfigured to execute the techniques for operating and programming theimplantable infusion device described in this disclosure.

The processor 103 (or any other processors described in this disclosure)can include one or more processors. The processor 103 can be connectedto the memory 115, the power source 104, the piezoelectric and/orelectrostrictive mechanical pumping catheter including segments 110-1through 110-N (substantially similar to segments 16 in FIG. 1A), thecommunication interface 108, the alarm 107, the sensing interface 111,and the micro-energy harvesting circuitry 106.

The memory 115 can be configured to store information within theimplantable infusion device during operation. The memory 115 can includea computer-readable storage medium. The memory 115, in some examples,can include a volatile memory. Examples of volatile memories includerandom access memories (RAM), dynamic random access memories (DRAM),static random access memories (SRAM), and any other forms of volatilememories known in the art. In some examples, the memory 115 can be usedto store program instructions for execution by the processor 103.

The memory 115, in one example, can be used by software or applicationsrunning on the implantable infusion device 100 (e.g., one or more ofcommunication interface 108 107 and sensing interface 111) totemporarily store information during program execution. The memory 115can be used for storing set(s) of infusion and control parameters,and/or other data, for example, This permits, as needed, infusion andcontrol parameter adjustment to configure the implantable infusiondevice to operate at settings that are safe and efficacious for eachindividual. Different parameters may have different effects on differentpatients, different diseases, and even different tissue.

The power source 104 can be used to provide power to the processor 103,piezoelectric and/or electrostrictive mechanical pumping catheterincluding segments 110-1 through 110-N, or other components of theimplantable infusion system. The power source 104 can be a primarybattery, for example, a lithium battery that once depleted will requirereplacement of the device. In another embodiment, power source 104 maybe a rechargeable battery, such as a lithium battery or any type ofrechargeable battery that may hold its charge for a period of time,depending upon the capacity of the battery, and may be recharged by auser on a regularly scheduled interval or as necessary.

In example configurations in which the power source 104 is rechargeable,the implantable infusion system can include a recharge circuit 113. Therecharge circuit 113 can use an inductive coupling technique to transferpower via an electromagnetic field. In some examples, the implantableinfusion catheter device 100 can includes an energy harvesting circuit106 to receive, convert, and provide power to the power source 104. Insome cases, the energy harvesting device 106 can include a bridgerectifier, a rectifier, a diode or transistor rectifier, and may includea voltage or current regulator.

The energy harvesting circuit 106 can, in some examples, can worktogether with, and receive power from, a RF wireless charger. Forexample, depending on the configuration of its electronics, antennas,and frequency ranges of operation, a RF wireless charging circuit canproduce a near-field electric or magnetic field that stores energy forcoupling into one or more target devices, or it can produce a far-fieldradiation pattern of traveling electromagnetic waves, or a combinationthereof. In some examples, the energy harvesting circuity can gatherenergy from sources such as patient body heat, blood flow, and motion,and provide energy directly to the device or via charging of theimplantable infusion system's circuitry.

The implantable infusion system 100 can use a piezoelectric and/orelectrostrictive mechanical pumping catheter that can be used to pump adrug or medicine in liquid or gas form from the reservoir 109 to anoutlet port of the reservoir, which can be connected to the catheter viaa catheter connector to provide the drug to the patient. The pumpingmechanism can include a piezoelectric-based material and/orelectrostrictive-based material with two or more pumping segments thatcan deform independently when voltage is applied. By alternating thevoltage application to the consecutive segments of the pumpingmechanism, a medium (fluid or gas) can be pushed out from the reservoirthrough the catheter. The design provides a check valve, piezo and/orelectrostrictive restriction mechanism, or other controller mechanism atthe outlet port of the reservoir chamber and at the two catheter endswhich used to control the flow direction.

The processor 103 can control the voltage output to each of the piezoand/or electrostrictive material segments contained within thepiezoelectric and/or electrostrictive mechanical pumping catheter, e.g.,segments 110-1 through 110-N. When the processor executes instructionsthat cause the voltage applied to the piezo and/or electrostrictivesegments to be decreased, the piezo and/or electrostrictive material inone or more of the segments 110-1 through 110-N can deform, e.g., upwardor downward, which can cause the fluid to be drawn into and fill thechamber, as described above with respect to FIG. 1A. As the processorcontrols the voltage to increase, the piezo and/or electrostrictivematerial can deform e.g., downward or upward, which can cause the fluidto be pushed out of the chamber and into the next chamber formed by asegment 110. The material can be deformed hundreds of times per second,thereby allowing delivery of drug from fractions of microliters overhours to thousands of microliters per hour. The processor 103 can alterthe amplitude and frequency of the electronic control pattern to varythe operation of the piezoelectric and/or electrostrictive mechanicalpump and hence regulate the rate of pumping and thus the amount of drugthat is expelled from the reservoir 110.

The rate of pumping can be controlled by the processor/control circuitry103 and control firmware. The downloadable programming parameters can beset via the wireless telemetry circuitry/external programmer 108.

The implantable infusion device can include a reservoir 109 that can becontained exterior to/separate from the implantable device 100. Thereservoir 109 can be a basin or container that holds the medicine ordrug (liquid or gas) intended for expulsion through an outlet port andcatheter to a target delivery site. The reservoir 109 can have variablecapacity ranging from any minimum amount measured in milliliters (mL) tohundreds of milliliters.

The reservoir 109 can be composed of one or more materials includingTitanium (Ti), Stainless steel (SS), Titanium alloys e.g., TAN(Titanium-Aluminum-Niobium), ceramics, non-degradable polymers,silicone, Kevlar®, etc. The connectors and fluid delivery pathway can becomposed of flexible or rigid tubing or other pathway composed of theseor other bio-suitable materials. These can be composed of, and coatedin, materials including silicone, Kevlar®, and many others.

The communication interface 108 of the implantable infusion device 100can include any type of communication network and may support wirelesscommunication based upon any type of techniques for transferring andreceiving data from a computing device. Wireless communication, forexample, includes WiFi, low range telemetry, Bluetooth or inductivecoupling. The external computing device used to program and communicatewith the implantable device for example, can include personal computingdevices, computers, servers, custom handheld devices, mobile devices,smart phones, and tablet computing devices that may program and controlinfusion and operational parameters of the implantable infusion device.

Implantable infusion device 100 can also include an alarm 107 and asensing interface 111 to detect, for example, the level of medicine ordrug (liquid or gas) present in the reservoir, the piezoelectric and/orelectrostrictive mechanical pumping flow rate, the capacity and currentlevel of the power source, catheter or drug delivery path occlusion, orstatus of the re-charge and energy harvesting circuits. The alarm 107and the sensing interface 111 can activate audible or tactical (e.g.,vibration) alerts when operational parameters are at or below programmedthresholds, device component failures occur, etc.

The implantable device 100 can also contain positional and motion(inertial, magnetic, etc.) sensing device(s) (e.g., single orcombination of accelerometer, gyroscope, or other motion and 3D sensingdevices) capable of sensing user position, motion, etc as part of thealarm 107 and sensing interface/circuitry 111. Utilizing a 3D sensingsystem, the device 100 can determine geo location information includinguser orientation data (e.g., roll, pitch, and yaw) and user locationtracking (x, y, z), and store this data in the device's resident memory.This data can be used to track user activity, to determine gain/loss inmobility, increase/decrease in user activity over time, and othervariances and/or changes of physiological related behavior.

One or more sensors (not depicted in FIG. 2) can also be incorporatedfor sensing aspects of the patient including, but not limited to,reservoir level, blood sugar, heart rate, blood pressure, bloodoxygenation, motion (roll, pitch, yaw, x, y, x, speed, etc.) sensorsincluding but not limited to GPS, gyro, rate, rotational, and bodytemperature. These sensors can work together with the one or more of thecomponents in FIG. 2 to provide full sensing, tracking, and storage ofcurrent and historical physiological data. The historical data can beutilized to gather and generate and interpret trending of the user dataover time. In this manner, the device 100 can acquire data from one ormore sensors via the sensor interface 111, store data in the memory 115representing the data, and in some examples, modify an operatingparameter of the device, e.g., pump speed, using the stored data. Insome examples, the device can use the trend information to modifying anoperating parameter of the device.

In some example implementations, the device 100 can transmit, e.g., viathe wireless telemetry circuity and communication interface 108, sensordata acquired by the one or more sensors, e.g., raw sensor data, and/orprocessed sensor data, e.g., analyzed and/or processed by processor 103,to one or more wearable devices, e.g., activity trackers. In thismanner, a user with a wearable device can receive important informationabout the infusion device 100 and/or the user. For example, informationabout the amount of medicine, e.g., insulin, in the reservoir based onreservoir level sensor data can be transmitted to the user along withthe user's blood sugar level based on data from a sensor incommunication with the user's blood.

The processor 103, the memory 115, the alarm 107 and the sensinginterface 111 can be used together or in combinations to supportalgorithms that can detect critical changes of the system or useractivity/physiology to triggers to notify the user or physicians ofimportant changes that require user or physician intervention. Differentparameters may have different effects on different patients, differentdiseases, and even different tissue. This data can be gathered by thedevice and analyzed by the device itself dynamically or archived forlater download and analyzing by an external device, e.g., via telemetrycircuitry 108. The device can have local on-board processing andprogramming support for improving its own operation and support to thepatient by analyzing this trend data.

FIGS. 3A-3B are conceptual diagrams illustrating an example of apiezoelectric and/or electrostrictive pumping mechanism that can be usedto implement various techniques of this disclosure. One example pumpthat can be used is the Bartels “mp5” or “mp6” micropump manufactured byBartels Mikrotechnik GmbH, FIGS. 3A-3B depict a pumping process thatcauses intake of a fluid from an internal or external reservoir (notdepicted) through an inlet port 40 of a pump 42 and into a first chamber44 by application of a voltage to an electrode/contact 46 connected to aflexible piezo and/or electrostrictive material 48 engaged to the firstchamber 44. Fluid in the second chamber 50 is forced out the outlet port52 by application of a voltage to an electrode/contact 54 connected to aflexible piezo and/or electrostrictive material 56 engaged to the secondchamber 50. The pump 42 includes valves 58A-D that can open/close in acoordinated manner with the chambers 44, 50 to allow fluid to be pumpedfrom the inlet port 40 to the outlet port 52 of each chamber and to thetarget site. A check valve can be between each of these pumps in orderto control and restrict backflow between the pumps and segments.

FIG. 4 is a schematic diagram illustrating an example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.The system of FIG. 4 can utilize the pumping catheter 10 shown in FIGS.1A-1C that includes deformable segments 16A-16F. The system of FIG. 4can include a piezoelectric and/or electrostrictive pressure pump master60 (similar to pump 42 in FIGS. 3A and 3B) in communication with afirst, e.g., unpressurized, reservoir 62 and a second, e.g.,pressurized, reservoir 64. The piezo and/or electrostrictive pressurepump master 60 and the pressurized reservoir 64 can help ensure thatfluid from the reservoir reaches the pumping catheter 10. In someexample configurations, neither reservoir 62 nor 64 is pressurized,however.

The pump master 60 can be in communication with a power source andcontrol electronics 20, which are described above with respect to FIG.2. Other configurations can include another piezo and/orelectrostrictive pressure pump at the outlet of the reservoir 64, forexample.

The first reservoir 62 can include a first refill port 68 that is incommunication with a remote second refill port 70 to allow a clinician,for example, to refill the medicament in the reservoir 62. The secondreservoir 64 can include an outlet port 72 in communication with acatheter 74 that includes a piezoelectric and/or electrostrictivepumping catheter 10. In some examples, the catheter 74 can furtherinclude a flow control valve 78, e.g., a check valve, placed proximal tothe piezoelectric and/or electrostrictive pumping catheter 10, or with aplurality of check valves, e.g., one for each pumping segment.

As described above, the implantable infusion system of FIG. 4 canutilize the pumping catheter 10 of FIGS. 1A-1C, which can include one ormore deformable segments 16. In other configurations, such as describedbelow with respect to FIGS. 5 and 6, example implantable infusionssystems can alternative pumping catheter designs.

FIG. 5 is a schematic diagram illustrating another example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.Many of the components of the system of FIG. 5 are similar to thosedescribed above with respect to FIG. 4. The system of FIG. 5 can includea piezoelectric and/or electrostrictive pressure pump master 60 incommunication with a first, e.g., unpressurized, reservoir 62 and asecond, e.g., pressurized, reservoir 64. The piezo and/orelectrostrictive pressure pump master 60 and the pressurized reservoir64 can help ensure that fluid from the reservoir reaches the first pumpin the catheter, e.g., piezo and/or electrostrictive slave 42A in FIG. 5(similar to pump 42 in FIGS. 3A and 3B). In some example configurations,neither reservoir 62 nor 64 is pressurized, however.

The pump master 60 can be in communication with a power source andcontrol electronics 20. Other configurations can include another piezoand/or electrostrictive pressure pump at the outlet of the reservoir 64,for example.

The first reservoir 62 can include a first refill port 68 that is incommunication with a remote second refill port 70 to allow a clinician,for example, to refill the medicament in the reservoir 62. The secondreservoir 64 can include an outlet port 72 in communication with acatheter 74 that includes a piezoelectric and/or electrostrictivepumping catheter system 76, which is different than the pumping catheter10 described with respect to FIG. 4.

In addition to the master piezoelectric and/or electrostrictive pump 60,the system of FIG. 5 can include a catheter 74 that includes first andsecond piezoelectric and/or electrostrictive pumps 42A, 42B (similar topump 42 in FIGS. 3A and 3B), e.g., piezo and/or electrostrictive slavesin FIG. 5, and a flow control valve 78, e.g., a check valve, placedproximal to the first piezoelectric and/or electrostrictive pump 42A, orwith a plurality of check valves, on for each pumping segment or pumps.An example piezoelectric and/or electrostrictive pump 42 is shown anddescribed in FIGS. 3A and 3B. The first and second piezoelectric and/orelectrostrictive pumps 42A, 42B, e.g., piezo and/or electrostrictiveslaves in FIG. 5, can be spaced apart from one another along a length ofthe catheter.

FIG. 6 is a schematic diagram illustrating another example implantableinfusion system that can utilize various piezoelectric and/orelectrostrictive pumping techniques, in accordance with this disclosure.The system of FIG. 6 can include a piezoelectric and/or electrostrictivepressure pump 60 in communication with a first, e.g., unpressurized,chamber or reservoir 62 and a second, e.g., pressurized, reservoir 64.The pump can be in communication with a power source and controlelectronics 20.

The first reservoir 62 can include a first refill port 68 that can be incommunication with a remote second refill port 70 to allow a clinician,for example, to refill the medicament in the reservoir 62. The firstreservoir 62 can additionally or alternatively include a programmableon/off illuminated refill port 65. Such a refill port 65 can beilluminated using materials including but not limited to one or morelight emitting diodes (LEDs), light pipe material, electro-luminescentmaterial, or a series of LED lights. The second, pressurized reservoir64 can include an outlet port 72 in communication with a catheter (orcatheter port) that includes a piezoelectric and/or electrostrictivecatheter system. In some example implementations, the catheter port 72can be illuminated as described above.

In contrast to the pumping catheter 76 of FIG. 5, which can includefirst and second piezoelectric and/or electrostrictive pumps 42A, 42B inthe catheter 74, the example catheter 74 shown in FIG. 6 can include apumping catheter 80 that can include a single piezoelectric and/orelectrostrictive pump 42, such as shown in FIGS. 3A and 3B, positionedwithin the catheter 74. As depicted in FIG. 6, the two chambers 44, 50of the piezo and/or electrostrictive pump 42 can be separated from oneanother by a distance, e.g., 1 centimeter to a number N centimeters.

The single catheter pump design of FIG. 6 can be thinner than the designdescribed above with respect to FIG. 5, which can be advantageous forimplantation within a patient's skull, for example. In addition, thecontrol of the single catheter pump design of FIG. 6 can be simpler thanthe design of FIG. 5 because there is only one opening and one closingmechanism in the catheter 74 to be controlled by a processor.

FIG. 7 illustrates a block diagram of another example of an implantableinfusion device 200. The device 200 of FIG. 7 can utilize apiezoelectric and/or electrostrictive mechanical pumping catheter thatincludes one or more miniature piezo and/or electrostrictive pumpingdevices contained within the catheter and connected to an externalreservoir, such as shown in FIGS. 5 and 6. The implantable infusiondevice 200 can include a first processor 203, e.g., an embeddedcontroller/processor, to control power and communication functionalityassociated with a power source 204, a recharge circuit 213, an energyharvesting circuit 224, and a communication interface 208.

The implantable infusion device 200 can further include a secondprocessor 202 to control and/or be in communication with a piezoelectricand/or electrostrictive mechanical pumping catheter 210, such as thepumping catheters 78 or 80 of FIGS. 5 and 6, a reservoir 209, an alarm207, and a sensing interface 211, configured to receive information fromone or more sensors, including biological sensors. The implantableinfusion device 200 can include one or more of the storage devices,communication and alarm, sensing interfaces, power sources,piezoelectric and/or electrostrictive mechanical pumps, reservoirs, andrecharge and energy harvesting circuits.

The pumping catheter 210 can be made from a biocompatible material oruniformly coated with a biocompatible material to attain a specifiedbiocompatibility. In some examples, the biocompatible materials includenatural or synthetic compounds or elements including, but not limitedto: metals, for example titanium or titanium alloy, or plastics such asmedical grade polyvinyl chloride (PVC), polyethylene (PE),polycarbonate, or polyether ether ketone (PEEK). Because the implantableinfusion device 200 can be implanted in a patient's body, it can bedesirable to reduce the overall size or dimensions of the housing of thedevice to minimize trauma and reduce the capability to feel the deviceexternal to the patient. In some instances, implantable infusion deviceimplantation can be directed to specific regions of the body such as theabdomen, which further constrains the size. Existing implantableinfusion devices can be bulky due to he components that are containedwithin the housing.

The reservoir 209 can also contain an outlet port to connect to acatheter for delivery medication to a target site (not shown). Inanother example, the housing of the device 200 may contain an inlet portattached to the reservoir 209 to refill the medicine or drug when it isdepleted.

In the example of FIG. 7, the implantable infusion device 200 caninclude a memory 215. The processor 203 and the memory 215 can besimilar to the processor 103 and the memory 115 described above withrespect to FIG. 2 and, for purposes of conciseness, will not bedescribed in detail again. The processor 203 can be connected to thememory 215, the power source 204, the piezoelectric and/orelectrostrictive mechanical pump 210, the communication interface 208,the alarm 207, and the sensing interface 211.

The power source 204 can be used to provide power to the processor 203,the piezoelectric and/or electrostrictive mechanical pumping catheter210, or other components of implantable infusion device 200. The powersource 204 can be similar to the power source 104 described above withrespect to FIG. 2 and, for purposes of conciseness, will not bedescribed in detail again. In an example configuration, the power source204 can be rechargeable and the implantable infusion device 200 caninclude a recharge circuit 213, e.g., utilizing inductive couplingtechniques to transfer power via an electromagnetic field. In someembodiments, implantable infusion device 200 includes an energyharvesting circuit 206 to receive, convert, and provide power to thepower source 204, similar to the circuit 106 described above withrespect to FIG. 2.

The implantable infusion device 200 can include a piezoelectric and/orelectrostrictive mechanical pumping catheter that can include a firstpump 210-1 (e.g., a single pump 42 of FIGS. 3A and 3B as described withrespect to FIG. 6) and, in some examples, a second pump 210-2 (e.g., twopumps 42 as described with respect to FIG. 5) that can be used to pump adrug or medicine in liquid or gas form from the reservoir 209 to theoutlet port 212 and into and through the catheter to provide the drug tothe patient, as shown in FIGS. 5 and 6.

The pumping catheter mechanism can include a series of self-containedmicro piezo-based and/or electrostrictive-based mechanisms that eachwork together to pump fluid through the catheter. By actuating thevoltage application to each pump contained in the catheter mechanism,and alternating pumping (opening/closing) of each consecutive pumphoused in the catheter in a controlled sequence, a medium (fluid or gas)can be pushed out from the chamber through the piezo and/orelectrostrictive pumps/catheter body. Multiples of these can becontrolled by the processing circuitry to control rate and flow, e.g.,voluntary peristaltic flow, of the fluid from the reservoir through thecatheter.

As shown in FIGS. 4-6, the system can include a check valve or piezoand/or electrostrictive compression mechanism on one side of thecatheter to control the flow direction. In some example configurations,the system can include a check valve or piezo and/or electrostrictivecompression mechanism on both sides of the catheter. The processor 203can control a voltage output to each piezoelectric and/orelectrostrictive mechanical pump housed in the catheter e.g., pumps210-1 and 210-2. As the voltage is applied to each piezo and/orelectrostrictive pump in the catheter, the specific pump is actuated topump, causing the fluid/gas to be drawn into and filling that particularpump. As the voltage is increased, the deformation of the piezo and/orelectrostrictive material of the pump can cause the fluid to be pushedout of that particular pump in the catheter and into the adjacentsegment of the catheter. While the previous piezo and/orelectrostrictive pump in the catheter remains closed, the next pump insequence can receive the fluid/gas pushed into that pump from theprevious one. That pump (3^(rd) in this sequence) is then triggered,which continues to force the fluid along the direction of flow. As thesequence of action continues forward down the catheter pumps, the lastone closed in the sequence can be opened (voltage removed), allowing thefluid to exit the catheter and be delivered to the target site. Thepumps can each be fired hundreds of times in a second. The processor 203may alter the amplitude and frequency of the electronic control patternto vary the operation of the piezoelectric and/or electrostrictivemechanical pump and hence regulate the amount and rate of drug that isexpelled from the reservoir 209.

The implantable infusion device 200 can include a reservoir 209. Thereservoir can include a container that holds the medicine or drug(liquid or gas) intended for expulsion through an outlet port andnon-pumping catheter to a target delivery site. Reservoir 209 may havevariable capacity example ranges can include about 20 mL, about 40 mL,about 60 mL, etc.

The communication interface 208 of the implantable infusion device 200can. be similar to the communication interface 108 described above.Implantable infusion device 200 may also include an alarm 207 andsensing interface 211 to detect, for example, the level of medicine ordrug (liquid or gas) present in the reservoir, the piezoelectric and/orelectrostrictive mechanical pump flow rate, the capacity of the powersource, catheter or drug delivery path occlusion, or status of therecharge and energy harvesting circuits. The alarm 207 and sensinginterface 211 may activate an audible or tactical (i.e., vibration)alerts when operational parameters are at or below programmedthresholds. Sensors may include pressure, etc.

The refill port 216 can incorporate an electronic coil or other sensingcircuitry to determine when a needle is inserted into the port to assistthe clinician during refill (to avoid accidental injection into the bodyrather than into the reservoir. A handheld device can be provided tosense the coil surrounding the refill port in order to locate the refillport and facilitate accurate insertion of the refill needle forinjection of drug to refill the infusion device.

The refill port 216 can be positioned in an easily accessible locationon the external surface of the implantable device's reservoir or can bepackaged in a separate remotely positioned location. The port canprovide a mechanism that resists microbial entry into the implantabledevice/reservoir/drug.

FIGS. 8A-8E depict conceptual diagrams illustrating an example pumpingsequence of an example piezoelectric and/or electrostrictive pumpingcatheter, in accordance with this disclosure. The example portion of acatheter 300 of FIGS. 8A-8E can be similar to the catheter 10 describedabove with respect to FIGS. 1A-1C. For simplicity, the example catheter300 depicted includes four segments 16, namely segments 16A-16D, and canutilize a right-to-left closing sequence beginning with segment 16A andending with segment 16D.

As seen in FIG. 8A, a processor, e.g., processor 103 of FIG. 2, cancontrol the segment 16A to close, and the processor 103 can controlsegments 16B-16D to remain open. A cross-sectional view of such aconfiguration was described above with respect to FIG. 1D.

In FIG. 8B, the processor can control the segment 16B to close, whichcan force the fluid 302 further along a length of the catheter 300. Asseen in FIG. 8B, the segment 16A can remain closed and the segments16B-16D can remain open.

In FIG. 8C, the processor can control the segment 16C to close, whichcan force the fluid 302 further along a length of the catheter 300. Asseen in FIG. 8C, the segments 16A, 16B can remain closed and thesegments 16D can remain open.

In FIG. 8D, the processor can control the last segment 16D to close(shown during a transition between an open state and a closed state),which can force the fluid 302 further along a length of the catheter300. In addition, the processor can control the segment 16A to open(shown during a transition between a closed state and an open state),which can draw the fluid 302 into the catheter 300. The segments 16B,16C can remain closed to prevent backflow.

Finally, FIG. 8E depicts the segments 16A and 16D of FIG. 8D fullytransitioned to an open state and a closed state, respectively, withsegments 16B, 16D closed. The pumping sequence of FIGS. 8A-8E, oranother pumping sequence, can be repeated in order to pump the fluid 302through the catheter.

Various Notes and Examples

Example 1 can include or use subject matter (e.g., a system, apparatus,method, article, or the like) that can include or use a pumping cathetercomprising a tubular member defining a lumen, the tubular member havinga proximal end, a distal end, and a plurality of deformable segmentsextending therebetween, and at least one pump positioned in at least oneof the plurality of deformable segments, wherein the at least one pumpis configured to receive a control signal and, in response, controllablydeform at least one segment to control at least one of a rate of fluidflow through the lumen and a volume of fluid through the lumen.

In Example 2, the subject matter of Example 1 may optionally includewherein the at least one pump comprises a first pump and a second pump,wherein the first pump is positioned in a first segment and the pump ispositioned in a second segment.

In Example 3, the subject matter of one or more of Examples 1 to 2 mayoptionally include a first check value positioned proximal to the pump.

In Example 4, the subject matter of one or more of Examples 1 to 3 mayoptionally include a second check value positioned distal to the atleast one pump.

In Example 5, the subject matter of one or more of Examples 1 to 4 mayoptionally include an implantable infusion device.

In Example 6, the subject matter of Example 5 may optionally includewherein the at least one pump includes at least one pump, and whereinthe implantable infusion device comprises at least one piezoelectricand/or electrostrictive pump.

In Example 7, the subject matter of Example 5 may optionally include atleast one sensor selected from the group consisting of pressure,positional, motion, locational, and biological sensors.

In Example 8, the subject matter of one or more of Examples 1 to 7 mayoptionally include, wherein the tubular member includes an outer memberand an inner member, and wherein the inner member includes the pluralityof segments and the at least one piezoelectric and/or electrostrictivepump.

In Example 9, the subject matter of one or more of Examples Ito 8 mayoptionally include, wherein the at least one pump includes at least oneof a piezoelectric material and an electrostrictive material.

In Example 10, the subject matter of one or more of Examples 1 to 9 mayoptionally include, wherein the at least one pump includes ashape-memory alloy.

Example 11 can include or use subject matter (e.g., a system apparatus,method, article, or the like) that can include or use an implantableinfusion device comprising a reservoir configured to retain a fluid tobe dispensed within a patient; at least one piezoelectric and/orelectrostrictive mechanical pumping catheter for dispensing the fluidcontained within the reservoir; a transceiver; and a processor tocontrol operation of the piezoelectric and/or electrostrictivemechanical pumping catheter.

In Example 12, the subject matter of Example 11 optionally include,wherein the piezoelectric and/or electrostrictive mechanical pumpingcatheter includes a pumping catheter including at least two deformablesegments, wherein the at least two deformable segments include at leasttwo piezoelectric and/or electrostrictive pumps configured to receive acontrol signal and, in response, controllably deform to control a fluidflow through a lumen of the catheter.

In Example 13, the subject matter of one or more of Examples 11 to 12may optionally include, wherein the piezoelectric and/orelectrostrictive mechanical pumping catheter includes a sensor, andwherein the processor is configured to determine pumping efficacy and todetect occlusions in the pumping catheter using data received from thesensor.

In Example 14 the subject matter of one or more of Examples 11 to 13 mayoptionally include, wherein the piezoelectric and/or electrostrictivemechanical pumping catheter system includes an energy harvestingcircuitry configured to gather and provide energy to the implantabledevice and circuitry.

In Example 15, the subject matter of one or more of Examples 11 to 14may optionally include, wherein the piezoelectric and/orelectrostrictive mechanical pumping catheter includes a catheterincluding at least two piezoelectric and/or electrostrictive pumps.

In Example 16, the subject matter of one or more of Examples 11 to 15may optionally include, wherein the piezoelectric and/orelectrostrictive mechanical pumping catheter includes a plurality ofpiezoelectric and/or electrostrictive pumps along a length of aninterior of the pumping catheter.

In Example 17, the subject matter of one or more of Examples 11 to 16may optionally include, wherein the at least one piezoelectric and/orelectrostrictive mechanical pumping catheter includes two or morepiezoelectric and/or electrostrictive mechanical pumping catheters.

In Example 18, the subject matter of one or more of Examples 11 to 17may optionally include, wherein the processor is configured tocommunicate wirelessly with the piezoelectric and/or electrostrictivemechanical pumping catheter using the transceiver.

In Example 19, the subject matter of one or more of Examples 11 to 18may optionally include, a memory device, wherein the processor isconfigured to acquire data corresponding to at least one characteristicof the pumping catheter from at least one sensor, and wherein theprocessor is configured to store at least some of the acquired data inthe memory device.

In Example 20, the subject matter of one or more of Examples 11 to 19may optionally include, wherein the processor is configured to analyzeat least some of the acquired data and, using the analyzed data, performat least one of the following modify an operating parameter of thedevice; and store data in the memory device representing trendinformation of the device.

In Example 21, the subject matter of one or more of Examples 11 to 20may optionally include, wherein the transceiver is configured totransmit at least some of the stored data to an external processor foranalysis.

In Example 22 the subject matter of one or more of Examples 11 to 21 mayoptionally include, wherein the processor is configured to: analyze atleast some of the acquired data to generate trend information of thedevice; store data in the memory device representing the trendinformation; and using the stored data, modify an operating parameter ofthe device.

In Example 23, the subject matter of one or more of Examples 11 to 22may optionally include at least one of a refill port configured to beilluminated and a catheter port configured to be illuminated to providevisibility through a patient's skin when implanted.

In Example 24, the subject matter of one or more of Examples 11 to 23may optionally include, wherein the processor is configured to generatean alarm signal to indicate at least one of the following conditions: alow battery, a pumping catheter occlusion, and a low reservoir levelutilizing data from one or more sensors.

In Example 25, the subject matter of one or more of Examples 11 to 24may optionally include, wherein the transceiver is configured towirelessly transmit pumping catheter data selected from the groupconsisting of the following: at least one programming parameter, a drugvolume level, and sensor data.

-   -   Each of these non-limiting examples may stand on its own, or may        be combined in various permutations or combinations with one or        more of the other examples.

The above detailed description includes references to the accompanyingdrawings, which form a part of the detailed description. The drawingsshow, by way of illustration, specific embodiments in which theinvention may be practiced. These embodiments are also referred toherein as “examples.” Such examples may include elements in addition tothose shown or described. However, the present inventors alsocontemplate examples in which only those elements shown or described areprovided. Moreover, the present inventors also contemplate examplesusing any combination or permutation of those elements shown ordescribed (or one or more aspects thereof), either with respect to aparticular example (or one or more aspects thereof), or with respect toother examples (or one or more aspects thereof) shown or describedherein.

In the event of inconsistent usages between this document and anydocuments so incorporated by reference, the usage in this documentcontrols.

In this document, the terms “a” or “an” are used, as is common in patentdocuments, to include one or more than one, independent of any otherinstances or usages of “at least one” or “one or more.” In thisdocument, the term “or” is used to refer to a nonexclusive or, such that“A or B” includes “A but not B,” “B but not A,” and “A and B,” unlessotherwise indicated. In this document, the terms “including” and “inwhich” are used as the plain-English equivalents of the respective terms“comprising” and “wherein.” Also, in the following claims, the terms“including” and “comprising” are open-ended, that is, a system, device,article, composition, formulation, or process that includes elements inaddition to those listed after such a term in a claim are still deemedto fall within the scope of that claim. Moreover, in the followingclaims, the terms “first,” “second,” and “third,” etc. are used merelyas labels, and are not intended to impose numerical requirements ontheir objects.

Method examples described herein may be machine or computer-implementedat least in part. Some examples may include a computer-readable mediumor machine-readable medium encoded with instructions operable toconfigure an electronic device to perform methods as described in theabove examples. An implementation of such methods may include code, suchas microcode, assembly language code, a higher-level language code, orthe like. Such code may include computer readable instructions forperforming various methods. The code may form portions of computerprogram products. Further, in an example, the code may be tangiblystored on one or more volatile, non-transitory, or non-volatile tangiblecomputer-readable media, such as during execution or at other times.Examples of these tangible computer-readable media may include, but arenot limited to, hard disks, removable magnetic disks, removable opticaldisks (e.g., compact disks and digital video disks), magnetic cassettes,memory cards or sticks, random access memories (RAMs), read onlymemories (ROMs), and the like.

The above description is intended to be illustrative, and notrestrictive. For example, the above-described examples (or one or moreaspects thereof) may be used in combination with each other. Otherembodiments may be used, such as by one of ordinary skill in the artupon reviewing the above description. The Abstract is provided to allowthe reader to quickly ascertain the nature of the technical disclosure.It is submitted with the understanding that it will not be used tointerpret or limit the scope or meaning of the claims. Also, in theabove Detailed Description, various features may be grouped together tostreamline the disclosure. This should not be interpreted as intendingthat an unclaimed disclosed feature is essential to any claim. Rather,inventive subject matter may lie in less than all features of aparticular disclosed embodiment. Thus, the following claims are herebyincorporated into the Detailed Description as examples or embodiments,with each claim standing on its own as a separate embodiment, and it iscontemplated that such embodiments may be combined with each other invarious combinations or permutations. The scope of the invention shouldbe determined with reference to the appended claims, along with the fullscope of equivalents to which such claims are entitled.

1. (canceled)
 2. A pumping catheter comprising: a catheter body having adeformable lumen, the catheter body including: a proximal end; a distalend; and one or more pumping segments extending between the proximal endand the distal end, wherein: each of the pumping segments are configuredto selectively deform the lumen by constricting or expanding the lumen;and at least one pump in communication with the pumping segments,wherein the at least one pump is configured to cooperate with thepumping segments to selectively deform the lumen to control one or moreof a rate of fluid flow through the lumen or a volume of fluid throughthe lumen.
 3. The pumping catheter of claim 2, wherein the at least onepump comprises a first pump and a second pump, wherein the first pump isin communication with a first pumping segment and the second pump is incommunication with a second pumping segment.
 4. The pumping catheter ofclaim 2, comprising: a check valve positioned proximal to the pump. 5.The pumping catheter of claim 2, comprising: a check valve positioneddistal to the pump.
 6. The pumping catheter of claim 2 in combinationwith an implantable infusion device.
 7. The pumping catheter of claim 6,wherein the implantable infusion device includes a reservoir.
 8. Thepumping catheter of claim 6, comprising: at least one sensor selectedfrom the group consisting of pressure, positional, motion, locational,and biological sensors.
 9. The pumping catheter of claim 2, wherein thetubular member includes an outer member and an inner member, and whereinthe inner member includes the plurality of segments and the at least onepiezoelectric and/or electrostrictive pump.
 10. The pumping catheter ofclaim 2, wherein the at least one pump includes one or more of apiezoelectric material or an electrostrictive material.
 11. The pumpingcatheter of claim 2, wherein the at least one pump includes ashape-memory alloy.
 12. An implantable infusion device, comprising: areservoir configured to retain a fluid to be dispensed within a patient;one or more pumping catheter for dispensing the fluid contained withinthe reservoir, wherein: each of the pumping catheters includes one ormore pumping segments; each of the pumping segments are configured toselectively deform a lumen of the pumping catheter by constricting orexpanding the lumen; and the pumping catheter includes at least one pumpin communication with the pumping segments, wherein the pump isconfigured to cooperate with the pumping segments to selectively deformthe lumen to control one or more of a rate of fluid flow through thelumen or a volume of fluid through the lumen; a transceiver: and acontroller in communication with the pump and configured to operate thepump to dispense the fluid from the reservoir and through the lumen. 13.The implantable infusion device of claim 11, wherein each of the pumpingcatheters includes at least two pumping segments, wherein each of thepumping segments includes the pumps.
 14. The implantable infusion deviceof claim 12, further comprising a sensor in communication with thepumping catheter, wherein the controller is configured to determinepumping efficacy and to detect occlusions in the pumping catheter usingdata received from the sensor.
 15. The implantable infusion device ofclaim 12, wherein the pumping catheter includes energy harvestingcircuitry configured to gather and provide energy to the implantabledevice and circuitry.
 17. The implantable infusion device of claim 12,wherein the at least one pump includes a plurality of pumps, and theplurality of pumps are located along a length of the pumping catheter.19. The implantable infusion device of claim 12, wherein the controlleris configured to communicate wirelessly with the pumping catheter usingthe transceiver.
 20. The implantable infusion device of claim 12,wherein the controller is configured to acquire data corresponding to atleast one characteristic of the pumping catheter from at least onesensor; and the controller is configured to store at least some of theacquired data in the memory device.
 21. The implantable infusion deviceof claim 20, wherein the controller is configured to analyze at leastsome of the acquired data and, using the analyzed data, the controlleris configured to modify an operating parameter of the implantableinfusion device.
 22. The implantable infusion device of claim 20,wherein the controller is configured to analyze at least some of theacquired data and, using the analyzed data, the controller is configuredto store data in the memory device representing trend information of thedevice.
 23. The implantable infusion device of claim 20, wherein thetransceiver is configured to transmit at least some of the stored datato the controller for analysis.
 24. The implantable infusion device ofclaim 20, wherein the controller is configured to: analyze at least someof the acquired data to generate trend information of the device; storedata in the memory device representing the trend information; and usingthe stored data, modify an operating parameter of the device.
 25. Theimplantable infusion device of claim 12, comprising at least one of arefill port configured to be illuminated and a catheter port configuredto be illuminated to provide visibility through a patient's skin whenimplanted.
 26. The implantable infusion device of claim 12, wherein thecontroller is configured to generate an alarm signal to indicate atleast one of the following conditions: a low battery, a pumping catheterocclusion, and a low reservoir level utilizing data from one or moresensors.
 27. The implantable infusion device of claim 12, wherein thetransceiver is configured to wirelessly transmit pumping catheter dataselected from the group consisting of the following: at least oneprogramming parameter, a drug volume level, and sensor data.